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Mediators of Kidney-Bone Communication in Childhood

Pubertal Assessment of Kidney-Bone Crosstalk

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02040740
Acronym
PAKC
Enrollment
26
Registered
2014-01-20
Start date
2013-03-31
Completion date
2013-06-30
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Scans, Fasting Blood Measures

Brief summary

An identified hormone linking bone and kidney function is Fibroblast Growth Factor-23 (FGF23). Data on the variation of FGF23 levels for bone and mineral metabolism in children are scarce. Currently it is assumed that meeting mineral requirements for the skeleton serves the body's overall needs. However, it is not clear as to whether this is true, particularly with growth. The contribution of dietary factors directly linked with the bone/kidney axis through measurement of intake (via 24hr recall) and kidney nutrient clearance (via serum and urinary analysis) will be included in investigations. Findings will serve as a springboard for delineating more specific mechanisms by which these systems become disordered and are influenced by diet. It is expected that adequacy of nutrients known to have a central role in bone function will optimize the hormonal milieu through crosstalk with the kidney. This effort will allow ongoing investigation in detecting and treating disturbances in mineral metabolism related to kidney disease, specifically in the pediatric population and broaden the understanding of kidney disease itself, as well as that of chronic diseases in which kidney health is of importance, such as diabetes and osteoporosis. Findings of this research may stress the importance of achieving dietary adequacy essential for establishing optimal body composition trajectories, particularly puberty.

Interventions

None listed

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
7 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* Male * ages 7-11y * Tanner stage less than or equal to 3 according to the criteria of Marshall and Tanner

Exclusion criteria

* History of Cushing's Syndrome, hyperprolactinemia, congenital (non-classic) adrenal hyperplasia, type 1 or 2 diabetes, disturbances in glucose or lipid metabolism * use of tobacco or consumption of alcohol; thyroid medication, diuretics, beta-blockers, or any medication that potentially could affect body composition, the lipid profile, insulin sensitivity, or blood pressure * eating disorders, cancer, kidney disease, endocrinopathy, liver disease, heart disease, or thyroid disease.

Design outcomes

Primary

MeasureTime frameDescription
Fibroblast Growth Factor 231 dayFasting plasma measure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026